Canadian GTIN Allocation Rules for Healthcare - GS1

Healthcare GTIN Allocation Rules
2.3. Data Requirements in Healthcare
2.3.1. Global Trade Item Number (GTIN)
By joining a GS1 Member Organisation the company receives a GS1 Company Prefix which gives the
company the ability to create GTINs and access to the GS1 Standards. The GS1 System is designed
to be used in any industry or any part of the public sector so that an individual company can select to
allocate GTINs using a GS1 Company Prefix from the GS1 Member Organisation of their choice.
However, some Regulators impose mandatory local requirements on the use of GTIN within their
jurisdiction (see 3, Regulators).
Attributes such as Batch Number, Expiration Date, Serial Number, etc. add value to the product when
combined with the GTIN in a GS1 bar code using the GS1 Application Identifiers. Their use enables
tracking & tracing systems and can contribute to improving patient safety. For more information see
the general guidelines http://www.gs1.org/healthcare.
Within the GS1 System the following attributes may only be used in association with a GTIN.
2.3.1.1. Batch Number
A Batch Number (Application Identifier (10)) is typically assigned at the point of manufacturer using, for
example, a production lot number, a shift number, a machine number, a time, or an internal production
code. The data is alphanumeric and length is variable up to 20 alphanumeric characters.
2.3.1.2. Expiration Date
An Expiration Date (Application Identifier (17)) is often referred to as expiry date or maximum durability
date and indicates the limit of consumption or use of a product (e.g., for pharmaceutical products it will
indicate the possibility of an indirect health risk resulting from the ineffectiveness of the product after
the date). It is always encoded as a fixed length six numeric characters with the structure YYMMDD
where:
■ YY = the tens and units of the year (e.g., 2003 = 03).
■ MM = the number of the month (e.g., January = 01).
■ DD = the number of the day of the relevant month (e.g., second day = 02).
An Expiration Date and Time may also be expressed (Application Identifier (7003)). This structure
is only used when the exact expiration time is critical to patient safety.
2.3.2. Serial Number
A Serial Number (Application Identifier (21)) is typically used on medical devices that need to be
individually tracked and traced (e.g., wheel chairs, pacemakers, MRI scanners).
03 October 2007, Final All contents copyright © GS1 2007 Page 9 of 26